TESTIMONY BEFORE THE U.S. HOUSE SUBCOMMITTEE ON ENERGY AND THE ENVIRONMENT
JESSICA SANDLER, M.H.S.
ON BEHALF OF:
DORIS DAY ANIMAL LEAGUE
PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS
IN DEFENSE OF ANIMALS
FRIENDS OF ANIMALS
FUND FOR ANIMALS
MEDICAL RESEARCH MODERNIZATION COMMITTEE
EARTH ISLAND INSTITUTE
ANIMAL LEGAL DEFENSE FUND
AMERICAN ANTI-VIVISECTION SOCIETY
Good morning, Mr. Chairman. My name is Jessica Sandler. I am pleased to be here today on behalf of a coalition of animal protection organizations to discuss the Environmental Protection Agency’s high production volume (HPV) chemical-testing program, and I thank you for inviting me. My background includes a master’s degree in environmental health sciences and almost 20 years’ experience as an occupational safety and health specialist, 10 of those with the Occupational Safety and Health Administration here in Washington, D.C. Because of my familiarity with chemical exposures and hazards, I was asked to look into this program in November 1998 when most of the animal protection community first learned of it.
We are appalled by the ramifications this program will have on animal welfare. The HPV program represents the most massive animal testing program in our nation’s history and is a major setback to recent strides toward more modern, more reliable, more cost-effective non-animal tests. In February, a coalition of every national animal protection organization in the country representing more than 10 million Americans signed a letter to Vice President Gore (who fast-tracked the program). The letter expressed our concerns and requested a delay in the implementation of the program in order to address these significant issues. My testimony will cover our concerns and discuss the changes we have been able to bring about to date in the HPV program, as well as the areas that still need to be addressed.
In October 1997, Vice President Gore committed to making data on the HPV chemicals publicly available. But instead of a concerted effort to collect the substantial amount of existing information, centralize it, and make it accessible, the EPA’s HPV chemical-testing program has turned into a huge “check-the-box” exercise in testing for testing’s sake that will do nothing to protect the public health and the environment. According to EPA officials, the only end result of all this testing will be to call for more testing. Yet, with the information already available on the HPV chemicals, many of them could be prioritized today. According to whistleblower calls we have received from EPA employees, the agency is not prepared to deal with the resulting HPV data in any meaningful manner, does not take the animal welfare issue seriously, and the HPV program is taking much-needed resources and staff away from important and authorized EPA programs.
Criticism From Other Quarters
There has been widespread criticism of the HPV chemical-testing program from many quarters other than the animal protection community. Eighteen members of Congress have written letters expressing concerns about the program. A D.C. public policy organization which focuses on right-to-know issues, The Unison Institute, has called the decision-making process for the program “obscure to most people. There are simple things that come with a standard government project, such as clear lines of authority and responsibility for data accuracy, which are not demarcated with this project It’s mind-boggling to think about the fluffiness of the situation.” With reference to Vice President Gore’s fast-tracking of the “right-to-know” testing plans, the American Industrial Health Council writes that “the speed with which the EPA has been asked to propose and finalize the rule [is] a reflection of a nonscientific, political agenda.”
The European Center for the Validation of Alternative Methods, an organization funded by the European Union, states with regard to the HPV program: “Traditional toxicologists with a vested interest in the continuation of check-list animal testing, and contract testing laboratories with a commercial interest in gaining new business, must be rejoicing. This is bad news for those of us who seek a scientifically rational approach to hazard prediction and risk assessment and the development and use of alternative methods.”
In addition, a number of environmental organizations have expressed concerns about the lack of any mechanism in the program to actually limit exposures to toxic chemicals, prevent toxic releases, or remove dangerous chemicals from the marketplace. In fact, the HPV program takes resources away from meaningful and effective EPA programs such as toxic release inventories and toxic-spill cleanups. While it is a windfall for animal testing laboratories, chemical manufacturing companies know that animal tests work in their favor because they are frequently inconclusive. Animal tests can actually clear chemicals already known to be hazardous. On the other hand, when the animals in the tests die, companies can accurately claim the results aren’t applicable to humans. Either way, these crude tests can be used to delay regulation or restriction of known hazardous chemicals.
Public Availability of Data
The EPA has conceded some of the issues we have raised about the HPV program since learning of it in November 1998 (only three months before the program’s implementation date). For example, when we looked at the list of chemicals to be tested, it was immediately apparent that the EPA and the Environmental Defense Fund’s claim that there is a “virtual vacuum of information” on these chemicals was unfounded. Whereas the original EPA publications on the HPV program stated that their report on the lack of data available on HPV chemicals was a definitive study, EPA officials now admit that it was, in fact, “a quick and dirty look in order to get the message out.” That type of advocacy is not what we, the public, have a right to expect from a federal regulatory agency.
We pointed out, and then documented in a report entitled “Availability of HPV Chemical Data,” that many of the chemicals had large amounts of publicly available data on them that the EPA and the EDF had overlooked. In fact, a number of chemicals on the list are substances that I, as a safety specialist, was taking off workplace shelves in the early 1980s because we were well aware back then how dangerous they were. Others have volumes of information available on them in the form of “Toxicological Profiles” issued by the Department of Health and Human Service’s Agency for Toxic Substances and Disease Registry (ATSDR).6 Some have been in commerce since the early 1900s and have been thoroughly studied: chemicals such as turpentine, rat poison, paint thinner, and leaded gasoline.
The Chemical Manufacturers Association study of data available on the high production volume chemicals states the results of their study underestimated the amount of existing data for a number of reasons, including the fact that they were forced to consider only data that fit the narrow constraints of the screening information data set (SIDS) protocols. So, for example, 90-day chronic toxicity animal studies were ignored because the SIDS protocol calls for 14-28 day studies. Therefore the CMA report concludes that “the amount of information publicly available is most likely an underestimate of the information that actually exists for the HPV substances.”7
The agency’s newest documents on the HPV program concede that much data is, in fact, available that needs to be considered and a new term “weight of evidence analysis” has now been introduced into those documents. The guidance document, “Determining the Adequacy of Existing Data,” discusses the manner in which existing data is to be considered. While we applaud the EPA for acknowledging this issue, we also note that the entire HPV program is based on the false assumption that there is no data available on these chemicals. Had the EPA considered all the data it is now telling companies to weigh, the “Challenge Program” might have taken a very different form.
National Academy of Sciences Report
The EPA and the EDF have repeatedly pointed to a National Academy of Sciences 1984 report, entitled “Toxicity Testing: Strategies to Determine Needs and Priorities” as a confirmatory study forming the basis of the HPV program. However, the second part of that report focuses on the issue of how existing data gaps should be filled. The conclusion is that “long lists of candidate chemicals need to be reduced to short lists through screening. Two key elements for screening are estimated human exposure and suspicion of toxic activity.” According to the National Academy of Sciences report, volume alone should not be the criteria for wholesale testing, as it is in the HPV program. Rather, it quite sensibly suggests that what is needed is “a scientific approach based on existing knowledge of chemistry and toxicology of related compounds and likely levels of human exposure.” Both of these elements are completely missing from the HPV program.
Program Circumvents TSCA Requirements and OECD Guidelines
EPA officials now say that the initial phase of the program will be a massive gathering and submission of data by the chemical companies. Yet the HPV program has no mechanism whereby the agency will review the data and determine what data is, in fact, missing. In response to our concerns, the agency has suggested that nonprofit charities shoulder the responsibility to identify data that has been overlooked by companies, an impossible burden given the thousands of tests plans and the rushed testing schedule.8 The EPA states it is following Organization for Economic Cooperation and Development (OECD) guidelines in the HPV program.9 The OECD plays an important role in the international harmonization of data for mutual acceptability. Yet the EPA is ignoring a series of safeguards the OECD has in place to minimize the numbers of animals used in tests.10
The agency also fails to address the issue of privately held company information. In fact, under the Toxic Substances Control Act, companies may be penalized for bringing forth previously withheld data regarding a chemical’s effects.11 During a 1991 Section 8(e) amnesty, the EPA received over 10,000 submissions of previously withheld data. Yet the EPA is not proposing a similar amnesty for the HPV program and it is reasonable to assume that, in many cases where old data show harmful effects, companies will prefer to run new animal tests rather than present the existing data. It is also questionable whether those 10,000 submissions were reviewed prior to determining the necessity for the HPV program.
EPA officials have stated that the rushed schedule on which the administration placed this program does not allow them to develop a scientifically defensible testing strategy or to review test plans. When pressed on this issue, they now say they will review those test plans that do not call for further testing but will not review those plans that do call for more testing on animals. Issue number one for the animal protection community is that the EPA not require, recommend, or sanction any animal tests until all available data are brought forward and thoroughly reviewed. We ask that the agency commit resources to a scientific review of the data and to making it publicly available prior to any requirement for further testing and that it purge the testing list of chemicals that are clearly not in need of further testing.12
This is no more than what the agency is required to do by statutory mandate and this TSCA requirement has been circumvented in this “voluntary” program. By law, it is the EPA’s responsibility to show that a lack of data exists prior to requiring further testing.13 Other ways in which normal government channels have been bypassed in the HPV program include the failure to date to provide public notification of the program by means of a Federal Register notice.
Arbitrary Testing Policies Devoid of Minimal Animal Welfare Considerations
In 1995, Science magazine reported that “Since its inception 25 years ago, the EPA has applied the same logic to hundreds of substances, extrapolating from high levels in animal studies to arrive at acceptable levels in humans. But that approach, say scientists both inside and outside the federal government, may no longer be the best way to safeguard human health.”
Other areas in which we have challenged the EPA include their testing protocols for genetic and terrestrial toxicity testing. The EPA was insisting on the use of animals for genetic toxicity screening even though its policy was not scientifically supportable and the OECD allowed the use of non-animal tests for this endpoint. Recently, the EPA announced it was reversing its 15-year adamantly held stance on this issue and would allow non-animal tests to be used. The EPA has also announced verbally that it will delete its requirement for the poisoning of birds in terrestrial toxicity tests since as we pointed out, the agency was not requiring the detailed exposure assessments used by the OECD prior to recommending these tests.
The EPA will also now allow the use of a combination test for chronic toxicity, reproduction, and development — a test they had previously adamantly opposed. Based on the use of this combination test, the agency now claims it will reduce the number of animals used in this program by 70 percent. Not only is that figure highly questionable (since the EPA is not requiring the combination test be used), but this change again points to the arbitrary nature of their original testing requirements and how devoid the original policy was of even the most minimal animal welfare considerations.
It is important to note that no new test methods have been developed and no breakthroughs achieved by the EPA and the EDF’s “TestSmart” initiative since the program was announced. They have merely conceded a few animal welfare concerns and are allowing some “refinements” of the animal tests. At the same time, it is important to keep in mind that an estimated 750,000 animals will still die in these tests.
The EPA and the EDF continue to publicly express their “excitement” at the massive amount of testing that will take place over the next five years, testing which they have stated they hope will start as soon as possible. According to recent press articles, animal testing laboratories are gearing up for the added business, hiring staff, and expanding their facilities.14 An EPA official was quoted as stating, “It’s a good time to be a lab owner and a bad time to be a lab rat.”15
EPA officials have repeatedly shown confusion over the very testing protocols they are requiring. In response to an ad campaign by one of the animal protection organizations, they stated that neither rabbits nor skin testing would be involved in the HPV program. I pointed out to them what their own protocols called for and they later announced publicly that both rabbits and dermal toxicity tests (death from penetration of chemicals through the skin) were, in fact, part of the testing protocols.
March 11 Position Statement by Animal Protection Coalition and Beyond
In an early March meeting, the coalition of animal protection organizations presented eight points of concern to the EPA and to Vice President Gore’s representative from the Council on Environmental Quality (please refer to the attached position statement). More than three months later, however, we are still awaiting a response to these issues. As mentioned previously, issues number one and two for the coalition are the assurance that there will be a thorough review of existing data by the EPA prior to requiring further testing and that the EPA will purge the testing list of those chemicals that do not belong on it. Also critical is the issue of validation of non-animal test methods and their incorporation in the program. Another office within the EPA, the Office of Pesticide Programs, is allowing the use of nonvalidated protocols while validation studies are performed, yet the EPA is refusing to push for the validation of several promising non-animal tests that could save thousands of animals’ lives in the HPV program. Examples of such tests include human cell lines tests to replace the mammalian lethality tests and the luminescent bacteria tests U.S. Geological Survey scientists use to replace acute fish toxicity tests.16
It is now mid-June three months after companies were due to sign up for the program. A critical EPA guidance document has yet to be issued providing companies with information on grouping chemicals into categories and using qualitative structure activity relationship analyses to reduce the testing performed. These analyses have the potential to greatly reduce the number of animals used in testing. In fact, University of Pittsburgh experts have estimated that up to 80 percent of the HPV chemicals could be analyzed using structure activity relationships, thus sparing hundreds of thousands of animals. This document was promised in December and still has not been issued. Another guidance document, also promised in December, to give companies guidance on how to conduct literature and data searches for existing information on chemicals was just issued in draft form last week. Considering the fact that 12 companies have signed up to start testing in 1999, we find the tardiness of the agency in issuing these documents reprehensible.
Reliance on One Advocacy Organization
I would also like to address the extent to which the EPA, our federal regulatory agency on hazardous chemicals in the environment, has ceded its authority in this matter to a nongovernmental organization. I have been present at EPA workshops on the HPV program in which agency representatives deferred to EDF officials when answering questions posed by company officials. For example, when one company representative queried the agency regarding the grouping of chemicals in order to reduce testing, the EDF representative provided the response that such categorization of chemicals would be severely frowned upon. The Council on Environmental Quality official has told us that the response to our eight issues of concern presented to Vice President Gore and the EPA is awaiting the EDF’s input. Never, in all my years of involvement with the federal government, have I seen such an odd dynamic at work. And it is not a dynamic that has served the public interest well.
Had the EPA not bypassed normal government channels in its rush to implement the HPV program, had there been a Federal Register notice on this program, had the EPA accepted comments from the public, had there been the opportunity for a scientific peer review of the underlying studies, had these issues been discussed during the development phase of the program, the program would have benefited and would have stood the chance of being a meaningful initiative. As it stands now, this testing program is not well thought out. And considering the fact that only two organizations (the EDF and the CMA) were involved in it and consulted on it, that should come as little surprise. Well-thought-out public policy comes from listening to the public. When federal agencies fail to do so, their policy inevitably fails, too.
We hope that future EPA programs will request, consider, and respond to the public and the scientific community’s comments. Unfortunately, we are well aware that other massive animal-testing programs are lined up behind the HPV chemical testing program and that, once again, no consideration has been given during their development to animal welfare issues. According to a British research scientist, the EPA’s proposed endocrine-disrupter testing program will kill an estimated 150 million animals. He goes on to state that projects in the United Kingdom which propose to use animals for experimental purposes, including for the testing of chemicals, require an ethical cost/benefit assessment before proceeding.17 Despite promises from the EPA to include us as stakeholders in future animal testing plans, we continue to run into roadblock after roadblock as we attempt to insert animal welfare concerns into the deliberations.
I appreciate the opportunity to present our concerns, and I would be happy to answer any questions you may have.
4 Examples of comments from industry participants include the following: “The current approach to the HPV program continues to be focused almost entirely on a need for check-box animal and ecological testing. This approach completely discounts the many advances in toxicology and risk assessment that have been made in the past few years, particularly science-based strategies that minimize the use of animals We are very concerned that EPA will be perceived as setting back the clock by approaching the HPV chemical initiative without taking advantage of the best science available” (Procter & Gamble Co., letter dated 13 Jan. 1999). “It is paramount that the agency be sure that all of the existing data on the HPV chemicals has been obtained, compiled, and evaluated and that clear criteria for the identification of data gaps has been established. This will necessitate EPA delaying the proposed aggressive start date for the testing to allow for a more comprehensive search of public and private databases” (Colgate-Palmolive Co., letter dated 12 Dec. 1998). “What is needed is a testing program based more on risk and utilizes the dollars to the best benefit of the American people versus testing for testing’s sake” (Synthetic Organic Chemical Manufacturers Association, BNA Daily Report for Executives, 13 Jan. 1999).
5 EPA documents on the HPV program originally stated that “EPA’s HPV chemical hazard information matrix captures the publicly available information on the HPV chemicals” (U.S. EPA, “Frequently Asked Questions”) and that “the EPA has reviewed the publicly available data and has learned that most of these chemicals have never been tested to determine how toxic they are to humans and the environment” (U.S. EPA, “Chemical Hazard Data Availability Study”).
6 For example, according to the EPA, polycyclic aromatic hydrocarbons (PAH’s) are missing acute, reproductive, and ecotoxicity data. Yet the ATSDR has issued a 420-page toxicological profile on 15 PAH’s, including a table entitled “Ongoing Studies of PAH’s.” The list of studies dates back to 1992 and includes acute inhalation and oral toxicity testing being done by the Meharry Medical College in Nashville and an abnormal fetal development being conducted at Yale University. 2,4-dichlorphenol is listed by the EPA as lacking chronic toxicity studies. According to a 1991 ATSDR toxicological profile, chronic toxicity studies have been done in humans via inhalation and skin, and orally in nonhumans.
7 “Several points need to be considered to put these results into perspective. First, lack of data electronically accessible by CAS Registry Numbers does not equate with lack of knowledge on the HPV substances. A second point to consider is that several of the test categories are inappropriate for certain HPV substances Because HPV substances are not screened for applicability of each test category, the amount of apparently “unavailable’ data indicated by this study is most likely an overestimate. In other words, a significant fraction of the apparently ‘unavailable’ data is probably inappropriate or irrelevant in assessing hazards and risksA third point is that individual companies may have exercised professional judgment (limited potential for exposure, structural similarity to tested chemicals, nontoxic substances) to make decisions regarding the ultimate need or priorities for chemical testing A fourth point is that this search for publicly accessible data, although comprehensive was not all-inclusive. A final point is that information that was located had to meet the evaluation criteria. For example, if a study administered a chemical intravenously, this study would have been rejected, even if it provided acute toxicity information.” (“Public Availability of SIDS-Related Testing Data for U.S. High Production Volume Chemicals,” Chemical Manufacturers Association)
10 The OECD requires companies to gather and submit all information (including exposure data) they can locate about a particular chemical in the form of a SIDS Initial Assessment Report and a SIDS dossier. These documents are then reviewed by a panel of experts who decide what, if any, further testing needs to be performed. Whereas the SIDS dossiers, and their review, help to ensure that testing is kept to a minimum, there is no attempt at such oversight by the EPA in the HPV Challenge Program.
11 According to a recent article in the New Jersey Law Journal (Feb. 15, 1999), “reviewing existing data to fill data gaps under the HPV testing initiative could expose chemical producers to liability under TSCA or FIFRA for failure to report adverse effects previously. Companies need to review their files with this possibility in mind.”
12 Examples include well-known and well-documented hazardous chemicals as well as chemicals considered safe food ingredients by the Food and Drug Administration. Also, characteristics of particular chemicals need to be considered before requiring a blanket series of tests on them (e.g., some chemicals are so acutely toxic that it does not make sense to require chronic toxicity tests on them; others preclude exposure by their actual physical characteristics or are closed-system intermediaries which do not present an exposure potential for either people or the environment). Other chemicals on the list are fatty acids and glycerides. No SIDS data has been identified by the EPA for them, yet a search for information on their metabolic and biological properties indicates that an extensive database exists. The EPA has removed some chemicals from the testing list, including hydrofluoric acid, sorbitol (a common chewing gum ingredient), bone meal, coconut oil, molasses, lard, and polymers, but this is still far from an adequate refinement of the list.
13 Section 4(a) of TSCA states that the administrator must find that there is “insufficient data and experience” and “there is or may be significant or substantial human exposure” prior to requiring that testing be conducted.
Click here to read more about the High Production Volume (HPV) Chemical testing Program.